What this study is
The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).
What's being tested
- Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
Intervention · BEHAVIORAL
Pivotal Response Treatment in autism center.
- Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)
Intervention · BEHAVIORAL
Pivotal Response Treatment in home environment.
Study details
- Official title
- Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
- Sponsor
- Stanford University
- Conditions
- Autism · Autism Spectrum Disorder · ASD
- Enrolling
- 120 people
- Starts
- 2022-10-18
- Est. completion
- 2028-09-15
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 2 Years – 5 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;
- Boys and girls between 2.0 and 5.11 years;
- Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;
- Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;
- Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;
- No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);
- No more than 60 minutes of individual 1:1 speech therapy per week;
- Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.
You can't join if
- Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
- Receiving ABA of 15 hours or more;
- Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
- Previous adequate Pivotal Response Treatment (PRT) trial;
- Participants living more than 30 miles from Stanford University;
- Child's primary language other than English.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openStanford University School of Medicine
Stanford, California, United States
- Beatrice Begley · Contact(650)736-1235PALprogram@stanford.edu
- Ellen Choi · Contact(650) 736-1235PALprogram@stanford.edu
- Antonio Y Hardan, MD · Principal investigator
Recruiting
Study team
Sponsor
Stanford University
Study ID IRB-61427
Principal investigator
Antonio Y. Hardan, MD
Stanford University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.